An interventional study of REAplan® and Dextrain Manipulandum® in Stroke, Acute, Stroke (Subacute) and Healthy Individuals (Controls), sponsored by University Hospital of Mont-Godinne. Recruiting at 2 sites in Belgium. Open to participants aged 40 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by University Hospital of Mont-Godinne · Not applicable, Interventional, and Basic science
This study aims to investigate whether the improvements achieved through motor skill learning (MSkL) with the ipsilesional upper limb (UL) are transferred to the contralesional UL during the (sub)acute stroke phase, and to identify the neural substrates underlying this inter-limb transfer. To achieve this, healthy individuals, acute and chronic stroke patients will perform proximal and distal MSkL tasks using serious games implemented on robotic devices. This will be complemented by behavioural assessments and multimodal MRI.
Over 3 consecutive days, healthy individuals, acute and chronic stroke patients will be evaluated and will train on the rehabilitation robot REAplan® (http://www.axinesis.com/) to assess proximal MSkL and on the manual dexterity tool Dextrain Manipulandum (https://www.dextrain.com/) to assess distal MSkL.
Healthy individuals, acute and chronic stroke patients will be randomised equally to 2 different groups. One group of participants will train over the 3 days on the serious game Circuit on the REAplan® and the game Targeting on the Dextrain Manipulandum. The other one will only be assessed on day 1 and day 3 on the serious games and will not have any training.
For proximal upper limb with the serious game Circuit, the participants will have to practice a complex circuit and move a cursor as quickly and accurately as possible by controlling the handle of the robot. A Reaching task and a Drawing task will be used to assess motor control.
For distal upper limb with the serious game Targeting, the participants will have to reach a series of targets with a cursor as quickly and accurately as possible by controlling their finger movements.
To explore the role of different brain structures in inter-limb transfer, Voxel-based Lesion Symptom Mapping (VLSM) based on high-resolution brain magnetic resonance imaging (MRI) scans, will be used to analyse the relationship between tissue damage and inter-limb transfer scores on a voxel-by-voxel basis.
Diffusion Tensor Imaging (DTI) will quantify the integrity of several white matter tracts, allowing through correlation analyses to unveil the white matter tracts crucial to achieve this transfer.
Moreover, several "classical" clinical scales and tests will be used to evaluate overall motor-sensory-cognitive functions.
8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.
This study's planned enrollment of 250 is above the median of 49 across 6,024 interventional studies indexed under Stroke.
Browse Stroke studies →University Hospital of Mont-Godinne is the lead sponsor of 24 studies on the registry; 6 are open to participants now.
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ACUTE STROKE PATIENTS:
Inclusion Criteria:
Exclusion Criteria:
HEALTHY INDIVIDUALS:
Inclusion Criteria:
Exclusion Criteria:
CHRONIC STROKE PATIENTS:
Inclusion Criteria:
Exclusion Criteria:
Participants will have trainings on the REAplan® robot using their ipsilesional arm with a serious game based on proximal motor skill learning and on the Dextrain Manipulandum device using their ipsilesional hand with a serious game based on distal MSkL. Participants will have assessment with each of their arms on the REAplan® robot with a serious game based on proximal motor skill learning and on the Dextrain Manipulandum device with each of their hands with a serious game based on distal MSkL
Device: REAplan® · Device: Dextrain Manipulandum®
Participants will only have assessment with each of their arms but not trainings on the REAplan® robot with a serious game based on proximal motor skill learning and on the Dextrain Manipulandum device with each of their hands with a serious game based on distal MSkL
Device: REAplan® · Device: Dextrain Manipulandum®
motor skill learning with the REAplan® rehabilitation robot, to be performed with ipsilesional arm
motor skill learning with the Dextrain Manipulandum® dexterity tool to be performed with ipsilesional hand
proximal motor control and motor skill assessement with the REAplan® rehabilitation robot, to be performed by each arm
distal motor skill assessment with the Dextrain Manipulandum® dexterity tool to be performed by each hand
Speed/Accuracy Trade-off (SAT) measured by the REAplan® robot
Speed/Accuracy Trade-off: mathematical computation of the relationship between speed and accuracy
Time frame: change between baseline (Day 1) and after training (Day 3)
force measured by the REAplan® robot
forces exerted in the wrong direction by each arm (Newtons)
Time frame: change between baseline (Day 1) and after training (Day 3)
Root Mean Square Error (RMSE) measured by the Dextrain Manipulandum
error between the coordinates of the target and the cursor
Time frame: change between baseline (Day 1) and after training (Day 3)
Speed/Accuracy Trade-off (SAT) measured by the Dextrain Manipulandum
Speed/Accuracy Trade-off: mathematical computation of the relationship between speed and accuracy
Time frame: change between baseline (Day 1) and after training (Day 3)
Hold time measured by the Dextrain Manipulandum
The amount of time the cursor remains inside the target zone
Time frame: change between baseline (Day 1) and after training (Day 3)
Coactivation measured by the Dextrain Manipulandum
binary measure of unasked fingers activated above the force threshold
Time frame: change between baseline (Day 1) and after training (Day 3)
Voxel-based Lesion Symptom Mapping (VLSM)
Diffusion Weighted Imaging (DWI)
Time frame: Baseline
Diffusion Tensor Imaging (DTI)
Fractional Anisotropy
Time frame: Baseline
Fugl Meyer Upper Extremity Test (FMA-UE)
Tests impairments of the upper limb after stroke. Range: 0-66. A higher score means less impairment.
Time frame: Day1
Oxford Cognitive Screen (OCS)
to identify cognitive impairments following stroke. Rather than providing only a single overall cognitive score, the OCS assesses several distinct cognitive domains (Language, Praxis, Number, Memory, Spatial and Controlled Attention) and produces a cognitive profile showing both preserved and impaired abilities.
Time frame: Day2
Action Research Arm Test (ARAT)
evaluate upper-limb motor function and activity performance. Range: 0-57. higher scores indicating better upper-limb motor function
Time frame: Day2
Fatigue Visual Analog Scale (VAS)
Visual Analog Scale to evaluate fatigue = a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points. Range : 0- 10. A higher score means a higher level of fatigue.
Time frame: Day 1
Intrinsic Motivation Inventory (IMI)
To assess participants' level of motivation and engagement in completing the proposed tasks. They will be asked to respond to a series of items concerning their interest in the activities, perceived competence, perceived effort, and the value they attribute to the task.
Time frame: Day3
Box and Block Test
To assess gross manual dexterity and unilateral upper-limb function.The participant is asked to move as many small wooden blocks as possible from one compartment of a box to another within 60 seconds. The task is performed separately with each hand. Score range: 0-150 for each hand. The score corresponds to the number of blocks successfully transferred in one minute. A higher score indicates better gross manual dexterity and upper-limb function.
Time frame: change between baseline (Day 1) and after training (Day 3)
Speed, Accuracy and Speed/Accuracy Trade-off (SAT) measured by the REAplan® robot on a Reaching task and on a Drawing task
A simple Reaching task and a Drawing task (mandala) to assess motor control on the REAplan(R) robot
Time frame: change between baseline (Day 1) and after training (Day 3)
Plan to share: Yes — Data Management Plan REDCap
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: The data will become available during the beginning of the study and for 10 years.
Access criteria: Login user of the Hospital of CHU UCL Namur -Site Godinne, Login user of the Hospital of Cliniques universitaires Saint-Luc
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